Development and Validation of Stability Indicating Assay Method By HPLC for Estimation Of Benzonatate

Abstract

Quality, purity, safety and efficacy of pharmaceuticals are important issues in drug therapy.A greater emphasis is being paid today on assurance of the quality and safety of a drug by monitoring and controlling the impurities and degradation products. The control of impurities and degradation products in dosage form became mandatory critical issue since their presence extensively diminishes both quality and safety of Active Pharmaceutical ingredient (API) and its dosage form. By the identification or characterization and quantification of the impurities and related substances, the risk of their impact on drug and its dosage form can be avoided or minimized. Various regulatory authorities like ICH, USFDA, Canadian Drug and Health agency are even emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). A stability indicating hyphenated analytical techniques has been developed and validated for Benzonatate as per International Conference on Harmonization.The Benzonatate standard was exposed to acid hydrolysis, alkali hydrolysis , oxidation , photolytic and thermolytic degradation condition and separated using Column HiQSil C18 (250 ´4.6mm,5µ) Mobile Phase is Methanol (0.01%), Formic Acid (70:30v/v), Flow rate 1ml/min Column Temperature is Ambient Detector set at 308nm RT (min): 4.220 ± 0.787 Asymmetry: 1.12  Plates (N): 4136. This method was validated for linearity, precision, accuracy, ruggedness and robustness. Results obtained after validation study indicating that the proposed single method allowed analysis of degraded product formed of Benzonatateformed under the various stress conditions.